Trial Outcomes & Findings for Repeat Surgery for Patients With Post-operative Trachomatous Trichiasis Trial (NCT NCT03886519)
NCT ID: NCT03886519
Last Updated: 2024-02-22
Results Overview
Presence of post-operative trichiasis defined as at least one trichiatic eyelashes or evidence of recent epilation. Trichiatic eyelashes are eyelashes touching the globe with the eye in the primary gaze. The outcome will be assessed at 3-6 months and at 12 months. If the eyelid has trichiasis at 2 weeks, but not at 3-6 months or 12 months, the eyelid will not be considered to have post-operative trichiasis. Due to COVID, the visit window for the Month 12 visits ranged from 10-20 months.
COMPLETED
NA
886 participants
10-20 months
2024-02-22
Participant Flow
A total of 886 participants were enrolled. Of those enrolled, 700 received surgery in accordance with the surgical protocol and the analyses are based on these participants.
Unit of analysis: Eyes
Participant milestones
| Measure |
BRAP (Bevel/Rotate/Advance Procedure)
The Bevel/rotate/advance procedure (BRAP) involves a partial-thickness beveled incision and tarsal advancement.
BRAP: Trichiasis surgery using the BRAP procedure
|
Trabut 3 mm
The Trabut procedure is a partial-thickness incision through the tarsal conjunctiva and tarsus parallel to the eyelid margin and 3 mm above the lash line.
Trabut: Trichiasis surgery using the Trabut procedure
|
|---|---|---|
|
Overall Study
STARTED
|
351 446
|
349 446
|
|
Overall Study
3-6 Month Visit
|
264 317
|
252 337
|
|
Overall Study
12 Month Visit
|
312 399
|
316 399
|
|
Overall Study
COMPLETED
|
335 425
|
328 420
|
|
Overall Study
NOT COMPLETED
|
16 21
|
21 26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Repeat Surgery for Patients With Post-operative Trachomatous Trichiasis Trial
Baseline characteristics by cohort
| Measure |
BRAP (Bevel/Rotate/Advance Procedure)
n=446 Eyes
The BRAP procedure involves a partial-thickness beveled incision, tarsal advancement and rotation
BRAP (Bevel/rotate/advance procedure): Trichiasis surgery using the BRAP procedure
|
Trabut 3 mm
n=446 Eyes
The Trabut procedure is a partial-thickness incision through the tarsal conjunctiva and tarsus parallel to the eyelid margin and 3 mm above the lash line.
Trabut: Trichiasis surgery using the Trabut procedure
|
Total
n=892 Eyes
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<40 years
|
92 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Age, Customized
40-60 years
|
189 Participants
n=5 Participants
|
193 Participants
n=7 Participants
|
382 Participants
n=5 Participants
|
|
Age, Customized
>60 years
|
70 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
285 Participants
n=5 Participants
|
273 Participants
n=7 Participants
|
558 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
351 Participants
n=5 Participants
|
349 Participants
n=7 Participants
|
700 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
351 Participants
n=5 Participants
|
349 Participants
n=7 Participants
|
700 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Ethiopia
|
351 participants
n=5 Participants
|
349 participants
n=7 Participants
|
700 participants
n=5 Participants
|
|
Baseline Trachomatous Trichiasis (TT) Severity
Mild
|
74 Eyes
n=14 Eyes
|
74 Eyes
n=23 Eyes
|
148 Eyes
n=50 Eyes
|
|
Baseline Trachomatous Trichiasis (TT) Severity
Moderate
|
84 Eyes
n=14 Eyes
|
104 Eyes
n=23 Eyes
|
188 Eyes
n=50 Eyes
|
|
Baseline Trachomatous Trichiasis (TT) Severity
Severe
|
288 Eyes
n=14 Eyes
|
268 Eyes
n=23 Eyes
|
556 Eyes
n=50 Eyes
|
PRIMARY outcome
Timeframe: 10-20 monthsPopulation: Data reported for those participants who completed the Month 3-6 and/or Month 12 assessments. A participant could have one or two eyes eligible for the study based on the number of eyes with TT prior to surgery.
Presence of post-operative trichiasis defined as at least one trichiatic eyelashes or evidence of recent epilation. Trichiatic eyelashes are eyelashes touching the globe with the eye in the primary gaze. The outcome will be assessed at 3-6 months and at 12 months. If the eyelid has trichiasis at 2 weeks, but not at 3-6 months or 12 months, the eyelid will not be considered to have post-operative trichiasis. Due to COVID, the visit window for the Month 12 visits ranged from 10-20 months.
Outcome measures
| Measure |
BRAP (Bevel/Rotate/Advance Procedure)
n=425 Eyelids
The BRAP procedure is a partial-thickness beveled incision
BRAP (Bevel/rotate/advance procedure): Trichiasis surgery using the BRAP procedure
|
Trabut 3 mm
n=420 Eyelids
The Trabut procedure is a partial-thickness incision through the tarsal conjunctiva and tarsus parallel to the eyelid margin and 3 mm above the lash line.
Trabut: Trichiasis surgery using the Trabut procedure
|
|---|---|---|
|
Number of Eyelids With Post-operative Trichiasis Within 12 Months
|
94 Eyelids
|
120 Eyelids
|
SECONDARY outcome
Timeframe: 3-6 monthsPresence of post-operative trichiasis defined as at least one trichiatic eyelash or evidence of recent epilation. Trichiatic eyelashes are eyelashes touching the globe with the eye in primary gaze.
Outcome measures
| Measure |
BRAP (Bevel/Rotate/Advance Procedure)
n=317 Eyelids
The BRAP procedure is a partial-thickness beveled incision
BRAP (Bevel/rotate/advance procedure): Trichiasis surgery using the BRAP procedure
|
Trabut 3 mm
n=337 Eyelids
The Trabut procedure is a partial-thickness incision through the tarsal conjunctiva and tarsus parallel to the eyelid margin and 3 mm above the lash line.
Trabut: Trichiasis surgery using the Trabut procedure
|
|---|---|---|
|
Number of Eyelids With Presence of Post-operative Trichiasis Within 3-6 Months
|
33 Eyelids
|
49 Eyelids
|
SECONDARY outcome
Timeframe: 3-6 monthsSeverity will be graded as mild, moderate, or severe based on the number of eyelashes touching the globe and the amount of eyelashes epilated. Trichiasis severity will be defined using the following categories: i. Mild: 1-4 eyelashes touching globe and no epilation OR \<1/3 eyelashes epilated and no eyelashes touching the globe ii. Moderate: 5-9 eyelashes touching globe and no epilation OR 1-4 eyelashes touching globe and \<1/3 eyelashes epilated iii. Severe: 5-9 eyelashes touching globe and \<1/3 eyelashes epilated OR 10+ eyelashes touching globe (regardless of epilation status) OR ≥1/3 eyelashes epilated (regardless of eyelashes touching globe) OR entire eyelid epilated
Outcome measures
| Measure |
BRAP (Bevel/Rotate/Advance Procedure)
n=317 Eyelids
The BRAP procedure is a partial-thickness beveled incision
BRAP (Bevel/rotate/advance procedure): Trichiasis surgery using the BRAP procedure
|
Trabut 3 mm
n=337 Eyelids
The Trabut procedure is a partial-thickness incision through the tarsal conjunctiva and tarsus parallel to the eyelid margin and 3 mm above the lash line.
Trabut: Trichiasis surgery using the Trabut procedure
|
|---|---|---|
|
Number of Eyelids With Each of the Trichiasis Severity Levels at 3-6 Months
Mild
|
21 Eyelids
|
32 Eyelids
|
|
Number of Eyelids With Each of the Trichiasis Severity Levels at 3-6 Months
Moderate
|
7 Eyelids
|
11 Eyelids
|
|
Number of Eyelids With Each of the Trichiasis Severity Levels at 3-6 Months
Severe
|
5 Eyelids
|
6 Eyelids
|
|
Number of Eyelids With Each of the Trichiasis Severity Levels at 3-6 Months
None
|
284 Eyelids
|
288 Eyelids
|
SECONDARY outcome
Timeframe: 10-20 monthsSeverity will be graded as mild, moderate, or severe based on the number of eyelashes touching the globe and the amount of eyelashes epilated. Trichiasis severity will be defined using the following categories: i. Mild: 1-4 eyelashes touching globe and no epilation OR \<1/3 eyelashes epilated and no eyelashes touching the globe ii. Moderate: 5-9 eyelashes touching globe and no epilation OR 1-4 eyelashes touching globe and \<1/3 eyelashes epilated iii. Severe: 5-9 eyelashes touching globe and \<1/3 eyelashes epilated OR 10+ eyelashes touching globe (regardless of epilation status) OR ≥1/3 eyelashes epilated (regardless of eyelashes touching globe) OR entire eyelid epilated. Due to COVID, the visit window for the Month 12 visits ranged from 10-20 months.
Outcome measures
| Measure |
BRAP (Bevel/Rotate/Advance Procedure)
n=399 Eyelids
The BRAP procedure is a partial-thickness beveled incision
BRAP (Bevel/rotate/advance procedure): Trichiasis surgery using the BRAP procedure
|
Trabut 3 mm
n=399 Eyelids
The Trabut procedure is a partial-thickness incision through the tarsal conjunctiva and tarsus parallel to the eyelid margin and 3 mm above the lash line.
Trabut: Trichiasis surgery using the Trabut procedure
|
|---|---|---|
|
Number of Eyelids With Each of the Trichiasis Severity Levels at 12 Months
None
|
310 Eyelids
|
281 Eyelids
|
|
Number of Eyelids With Each of the Trichiasis Severity Levels at 12 Months
Mild
|
47 Eyelids
|
76 Eyelids
|
|
Number of Eyelids With Each of the Trichiasis Severity Levels at 12 Months
Moderate
|
24 Eyelids
|
23 Eyelids
|
|
Number of Eyelids With Each of the Trichiasis Severity Levels at 12 Months
Severe
|
18 Eyelids
|
19 Eyelids
|
SECONDARY outcome
Timeframe: 10-20 monthsPopulation: Analysis limited to eyelids with PTT at 3-6 months that also had a 12-month visit.
The change in PTT severity between 3-6 months and 12 months will be measured in eyes with PTT at 3-6 months that also were examined at the 12-month visit. Change will be measured in the difference in the number of categories between 3-6 month and 1 year outcome. For example, Mild to Severe would be a 2 category change.
Outcome measures
| Measure |
BRAP (Bevel/Rotate/Advance Procedure)
n=24 Participants
The BRAP procedure is a partial-thickness beveled incision
BRAP (Bevel/rotate/advance procedure): Trichiasis surgery using the BRAP procedure
|
Trabut 3 mm
n=40 Participants
The Trabut procedure is a partial-thickness incision through the tarsal conjunctiva and tarsus parallel to the eyelid margin and 3 mm above the lash line.
Trabut: Trichiasis surgery using the Trabut procedure
|
|---|---|---|
|
Change in Severity of Post-operative Trichiasis Between 3-6 Months and 1 Year Using Grading System
No change
|
21 Eyelids
|
43 Eyelids
|
|
Change in Severity of Post-operative Trichiasis Between 3-6 Months and 1 Year Using Grading System
1 category worse
|
6 Eyelids
|
1 Eyelids
|
|
Change in Severity of Post-operative Trichiasis Between 3-6 Months and 1 Year Using Grading System
2 categories worse
|
1 Eyelids
|
3 Eyelids
|
SECONDARY outcome
Timeframe: 3-6 monthsThe examiner will assess for eyelid contour abnormalities (ECA) and grade the abnormalities as mild, moderate, or severe. For the analysis, no abnormality and mild eyelid contour abnormality will be combined, and moderate and severe eyelid contour abnormality will be combined. For secondary analyses, the investigators will classify eyelid contour abnormalities using the photographs to capture the full range of ECA categories: none, mild, moderate, and severe. The definitions for the categories are: 1) Mild: Vertical deviation from the natural contour, 1 mm in height (less than half the pupil height in daylight) and affecting 1/3 of horizontal eyelid length. 2) Moderate: Vertical deviation from the natural contour 1-2 mm in height (about the pupil height in daylight) or affecting 1/3-2/3 of horizontal eyelid length 3) Severe: Vertical deviation from the natural contour 2 mm in height (more than the pupil height in daylight) or a defect \>2/3 of the horizontal eyelid len
Outcome measures
| Measure |
BRAP (Bevel/Rotate/Advance Procedure)
n=317 Eyelids
The BRAP procedure is a partial-thickness beveled incision
BRAP (Bevel/rotate/advance procedure): Trichiasis surgery using the BRAP procedure
|
Trabut 3 mm
n=337 Eyelids
The Trabut procedure is a partial-thickness incision through the tarsal conjunctiva and tarsus parallel to the eyelid margin and 3 mm above the lash line.
Trabut: Trichiasis surgery using the Trabut procedure
|
|---|---|---|
|
Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 3-6 Months
None/Mild
|
225 Eyelids
|
236 Eyelids
|
|
Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 3-6 Months
Moderate/Severe
|
92 Eyelids
|
101 Eyelids
|
SECONDARY outcome
Timeframe: 10-20 monthsThe examiner in the field will assess for eyelid contour abnormalities and grade the abnormalities as mild, moderate, or severe. For the analysis, no abnormality and mild eyelid contour abnormality will be combined, and moderate and severe eyelid contour abnormality will be combined. For secondary analyses, the investigators will classify eyelid contour abnormalities using the photographs to capture the full range of ECA categories: none, mild, moderate, and severe. The definitions for the categories are: 1) Mild: Vertical deviation from the natural contour, 1 mm in height (less than half the pupil height in daylight) and affecting 1/3 of horizontal eyelid length. 2) Moderate: Vertical deviation from the natural contour 1-2 mm in height (about the pupil height in daylight) or affecting 1/3-2/3 of horizontal eyelid length 3) Severe: Vertical deviation from the natural contour 2 mm in height (more than the pupil height in daylight) or a defect \>2/3 of the horizontal eyelid length
Outcome measures
| Measure |
BRAP (Bevel/Rotate/Advance Procedure)
n=399 Eyelids
The BRAP procedure is a partial-thickness beveled incision
BRAP (Bevel/rotate/advance procedure): Trichiasis surgery using the BRAP procedure
|
Trabut 3 mm
n=399 Eyelids
The Trabut procedure is a partial-thickness incision through the tarsal conjunctiva and tarsus parallel to the eyelid margin and 3 mm above the lash line.
Trabut: Trichiasis surgery using the Trabut procedure
|
|---|---|---|
|
Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 12 Months
None/Mild
|
317 Eyelids
|
334 Eyelids
|
|
Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 12 Months
Moderate/Severe
|
82 Eyelids
|
65 Eyelids
|
SECONDARY outcome
Timeframe: 10-20 monthsPopulation: Data reported for those participants who completed the Month 3-6 and/or Month 12 assessments. A participant could have one or two eyes eligible for the study based on the number of eyes with TT prior to surgery.
Pyogenic granulomas occasionally develop after trichiasis surgery. It is thought that this is a response to a foreign material, such as a sutures or an incision edge. All granulomas will be noted regardless of size. The investigators will count granulomas observed at the 3-6 month visit (including participants where the granuloma was removed) and granulomas observed at the 12 month visit. Due to COVID, the visit window for the Month 12 visits ranged from 10-20 months.
Outcome measures
| Measure |
BRAP (Bevel/Rotate/Advance Procedure)
n=425 eyelids
The BRAP procedure is a partial-thickness beveled incision
BRAP (Bevel/rotate/advance procedure): Trichiasis surgery using the BRAP procedure
|
Trabut 3 mm
n=420 eyelids
The Trabut procedure is a partial-thickness incision through the tarsal conjunctiva and tarsus parallel to the eyelid margin and 3 mm above the lash line.
Trabut: Trichiasis surgery using the Trabut procedure
|
|---|---|---|
|
Cumulative Number of Eyelids With Presence of Pyogenic Granulomas Within 10-20 Months
|
3 eyelids
|
10 eyelids
|
Adverse Events
BRAP (Bevel/Rotate/Advance Procedure)
Trabut 3 mm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Emily Gower, PhD
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place